ACYCLOVIR

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ACYCLOVIR (ACICLOVIR)

Composition:

Active substance: aciclovir;

1 g of ointment contains aciclovir 25 mg;

Excipients: polyethylene glycol 1500, polyethylene glycol 400, propylene glycol, emulsifier No. 1.

Pharmaceutical form. Ointment.

Main physicochemical properties: white-colored ointment.

Pharmacotherapeutic group.

Antiviral agents. ATC code D06B B03.

Pharmacological properties.

Pharmacodynamics.

Aciclovir is an antiviral agent with high in vitro activity against herpes simplex virus types I and II. Its toxic effect on host organism cells is minimal. Upon entry into herpes-infected cells, aciclovir is phosphorylated to form the active compound, aciclovir triphosphate. The first step of this process depends on the presence of virally encoded thymidine kinase. Aciclovir triphosphate acts as both an inhibitor and a substrate for viral DNA polymerase, thereby preventing further viral DNA synthesis without affecting normal cellular processes.

Pharmacokinetics.

Systemic absorption of aciclovir following repeated topical application of the ointment is minimal.

Clinical characteristics.

Indications.

Infections of the lips and face caused by herpes simplex virus (Herpes labialis).

Contraindications.

Hypersensitivity to acyclovir, valacyclovir, propylene glycol, or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

No interactions identified.

Special precautions for use.

Avoid accidental contact of the ointment with the eyes.

Patients with herpes labialis should be advised to avoid transmitting the virus to others through direct contact, especially when active lesions are present.

The product should be used only for the treatment of herpes lesions on the lips and face. The ointment should not be applied to mucous membranes of the oral cavity or eyes, and should not be used for the treatment of genital herpes. Patients with particularly severe manifestations of Herpes labialis should consult a physician.

Use in immunocompromised individuals is not recommended without prior medical consultation. Such patients should consult a physician regarding the treatment of any infection.

Use during pregnancy or breastfeeding.

The product is recommended for use in pregnant and breastfeeding women only when, in the opinion of the physician, the expected benefit outweighs the potential risk.

Ability to influence reaction rate while driving or operating machinery.

No data available.

Method of administration and dosage.

The product is intended for external use only.

For children aged 12 years and older, and adults: The ointment should be applied 5 times daily at approximately 4-hour intervals, except during nighttime. It is important to start treatment as early as possible at the onset of infection, preferably during the prodromal period or erythema stage. Treatment may also be initiated at later stages—papules or blisters.

Treatment should last for at least 4 days. If healing has not occurred, treatment may be continued for up to 10 days. If symptoms have not resolved after 10 days of treatment, the patient should consult a physician. Hands should be washed before and after applying the ointment, and excessive rubbing or contact with towels on affected areas should be avoided to prevent exacerbation or transmission of infection.

Children. There is insufficient data on the safety of using the product in children under 12 years of age; therefore, its use is not recommended in this age group.

Overdose.

No adverse effects have been reported following oral or topical application of the entire tube of ointment due to minimal systemic exposure. In case of suspected overdose, medical advice should be sought.

Side effects.

In some patients, temporary transient burning or stinging pain may occur after application of the ointment. Approximately in 5% of patients, mild skin drying and desquamation were observed. In a small number of patients, erythema (redness) and itching occurred. Very rarely, cases of contact dermatitis have been reported following the use of acyclovir preparations; however, these cases were more often associated with components of the ointment base rather than with acyclovir itself. Isolated reports of immediate hypersensitivity reactions, including angioneurotic edema, have been reported following topical application of acyclovir.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the package.

Storage conditions. Store at a temperature not exceeding 25 ºC, in a place inaccessible to children.

Packaging. 5 g or 10 g in a tube, in a carton.

Prescription status. Over-the-counter (without prescription).

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and address of its business activity.

4, Korolova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.